Topical SGX302 for Mild-to-Moderate Psoriasis

Soligenix

Status and phase: Enrolling; Phase 2

Conditions: Psoriasis; Plaque Psoriasis; Psoriasis Vulgaris

Treatments: Drug: Placebo; Drug: Hypericin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05442190

HPN-PSR-01

Details and patient eligibility

About

To evaluate SGX302 (topical hypericin ointment and gel) with visible light in an initial 18-week treatment course for improving lesions in patients with mild-to-moderate psoriasis.

Enrollment: 47 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6-months duration that involves the body (trunk and/or limbs) that is amenable to topical treatment and opaque coverage after application.
• Have a static Investigator Global Assessment (IGA)/Psoriasis Area and Severity Index (PASI) of disease severity of mild or moderate on the body (trunk and/or limbs).
• Have lesions involving 2-30% of the body (trunk and/or limbs). For subjects with scalp psoriasis included in the treatment area, the total treatment area on body and scalp must not exceed 30%.

Exclusion criteria

• Use of topical anti psoriatic therapy within one week prior to the beginning of the study and willing to not use other psoriasis treatments for 4 weeks following completion of the treatment portion of the study.
• Received systemic biologic therapy to treat psoriasis within 12 weeks prior to the beginning of the study.
• Received systemic psoriasis therapy within 4 weeks prior to the beginning of the study.
• Received phototherapy (including laser) or photodynamic (light activated drug) therapy within 4 weeks prior to the beginning of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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47 participants in 3 patient groups, including a placebo group

SGX302 Ointment (0.25 % Hypericin)

Experimental group

Description:

SGX302 (0.25 % hypericin) ointment will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks.

Treatment:

Drug: Hypericin

Placebo (Ointment without Hypericin)

Placebo Comparator group

Description:

Placebo ointment will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks.

Treatment:

Drug: Placebo

SGX302 Gel (0.25 % hypericin)

Experimental group

Description:

SGX302 (0.25 % hypericin) gelt will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks.

Treatment:

Drug: Hypericin